Summary
Device records identify The Brewer Company, LLC as labeler of the Access High-Low Table, model 6501. The record describes support and positioning during examinations and minor procedures, reports commercial distribution, and identifies FDA product code LGX with premarket exemption. This is device identification and exemption evidence, not FDA clearance. [1]
The model 6501 record supports Brewer’s medical-device role but does not establish the regulatory status of every current Access PLUS, FLEX PLUS, Assist or fixed-height configuration. Establishment registration and company-reported ISO certification are not product approvals. [1][2]
Applicant-name research identified five older 510(k) records for products including IV stands, a dental chair, a crib and a powered seat. Their links to the current commercial portfolio have not been established, so they are excluded from current-product clearance counts. A missing current clearance count does not mean the displayed tables require 510(k) clearance. [12][16][15][14][13]
FDA recall Z-2531-2018 documents a Class II correction of specified Access Hi-Low 6501-XX tables for over-crimped wire-harness connectors. Initiated March 29, 2018, the event was terminated August 29, 2019. It is retained as historical, lot-specific context and is not evidence that current PLUS tables are recalled. [17]